Strategy of Early Improvement of Tissue Oxygenation Decrease the Mortality of Severe Sepsis and Septic Shock

NCT01310790 | Completed Phase 4 DMC

• 1 other identifier: CSSN-6091-DaweiLiu
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

The impact of lactate guided therapy on septic shock has not been extensively investigated, however the goal directed therapy has been used for years. The investigators aim was to test the hypothesis that lactate directed hemodynamic therapy is associated with improving the outcome of patients with septic shock by comparing different goal directed strategies which have been commonly recommended clinically. In this multicenter, randomized trial, the investigators assigned patients with septic shock to three groups: Patients were treated with hemodynamic therapy directed either by conventional parameters treatment (control group), or central venous oxygen saturation (ScvO2), or blood lactate respectively in each group. The primary outcome was the rate of death at 28 days after randomization and in-hospital mortality; secondary end points include hemodynamic states, time to goal-achievement.

Conditions

Shock, Septic

Keywords

septic shock; lactic acid clearance; ScVO2

Outcome Measures

Primary Outcomes (1)

• mortality

  Because some patients stayed in hospital for a quite long time,so when we made statistics,we defined that if the patient still alive after involved 90 days, this patient was in-hospital lived.

  in-hospital

Interventions

lactate group:lactate acide clearance directed group; ScvO2 group:ScvO2 directed group;control group PROCEDURE

Patients assigned to lactate group started with the resuscitation to achieve a CVP of 8 to 12 mmHg and MAP 65 to 90 mmHg. Then if ScvO2 was less than 70 percent, red cells were transfused to achieve a hematocrit of at least 30 percent. After the CVP, MAP, and hematocrit achieved the goals, dobutamine was given until the ScvO2 was 70 percent or higher. Arterial blood lactate concentration was obtained at 6 hours and try to achieve lactate clearance was \>30%. Patients in the ScvO2 group received the treatment as ScvO2 directed therapy protocol for at least 6 hours and maintained for 72 hours. The protocol was the same as that of lactated directed therapy with the exception of blood lactate concentration testing. Patients in the control group received the treatment as the same protocol for maintaining CVP and MAP in that of lactated directed therapy. ScvO2 and arterial blood lactated concentration were not necessary to obtain.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• severe sepsis and septic shock patients

You may not qualify if:

• \<18 years old;
• pregnant woman;
• AMI;
• cerebral hemorrhage;
• contraindication for S-G catheter
• Brainstem death

Sponsors & Collaborators

• Chinese Septic Shock Network: lead

Study Sites (1)

Critical Care Department, Peking Union Medical Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Dawei Liu, M.D

  Peking Union Medical College Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 8, 2011
• First Posted: March 9, 2011
• Study Start: October 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 9, 2011

Record last verified: 2011-03

Locations

CN (1)